In short
This article discusses a clinical trial investigating the use of Phleum Pratense Pollen Extract, Enriched, for diagnosing allergies to Phleum pratense (Timothy grass) and Dactylis glomerata (Orchard grass). The study aims to determine the optimal concentration of the allergen extract that produces a skin reaction equivalent to a standard histamine solution, as well as assess its safety and tolerability.
At a glance
- Study Drug
- Phleum Pratense Pollen Extract, Enriched
- Purpose
- Diagnosis of allergy to Phleum pratense and Dactylis glomerata
- Primary Objective
- Determine optimal concentration for skin prick test
- Secondary Objective
- Assess safety and tolerability of allergen extracts
- Participant Age Range
- 18-64 years
- Key Inclusion Criteria
- Positive allergy history, positive skin prick test or specific IgE
- Key Exclusion Criteria
- Recent immunotherapy, unstable clinical conditions, pregnancy
- Primary Endpoint
- Wheal area measurement in skin prick test
- Secondary Endpoints
- Adverse event rate, administration site reactions
What is Phleum Pratense?
Phleum pratense, commonly known as Timothy grass, is a type of grass that produces pollen known to cause allergic reactions in many people. This grass is widespread in many parts of the world, making it a significant source of allergies.
About the Medication
The medication being studied is called "Prick test of enriched Phleum pratense pollen extract." It's a solution used for a skin-prick test, which is a method to diagnose allergies. This product contains an extract from Phleum pratense pollen, which has been enriched to enhance its effectiveness in detecting allergies.
Key points about this medication:
- It's manufactured by INMUNOTEK S.L.
- It's classified under "Tests for Allergic Diseases" in medical categorization
- It's not an oral medication, but a solution applied to the skin during allergy testing
- The maximum daily dose is 2 drops, with a total maximum dose of 6 nanoliters
Medical Conditions Treated
This medication is specifically designed to diagnose allergies to Phleum pratense (Timothy grass) and Dactylis glomerata (Orchard grass). These grasses are common causes of hay fever and other allergic reactions, particularly in areas where these grasses are prevalent.
Symptoms of grass pollen allergy may include:
- Sneezing
- Runny or stuffy nose
- Itchy eyes, nose, and throat
- Watery eyes
- In some cases, asthma symptoms
How the Test Works
The skin-prick test using this solution helps diagnose allergies by observing the skin's reaction. Here's how it works:
- A small amount of the allergen extract is placed on the skin, usually on the forearm or back.
- The skin is then pricked with a small, sterile probe to allow the solution to enter just below the skin's surface.
- If you're allergic to the substance, a small, raised, red, and itchy bump (called a wheal) will appear at the site within about 15-20 minutes.
- The size of the wheal is measured to determine the severity of the allergy.
Eligibility for the Test
Not everyone is eligible for this allergy test. Here are some key eligibility criteria:
- Age: Must be between 18 and 64 years old
- Location: Should live in an area where Phleum pratense and Dactylis glomerata allergies are common
- Medical history: Should have a history of inhalant allergy (such as rhinitis, rhinoconjunctivitis, or asthma) to these grasses
- Previous tests: Should have had a positive prick test or presence of specific IgE antibodies to these allergens
Safety Considerations
While the skin-prick test is generally safe, there are some important safety considerations:
- The test is not suitable for pregnant or breastfeeding women
- People with certain medical conditions (like hyperthyroidism, hypertension, or heart disease) may not be eligible
- Those with a known allergy to phenol should not undergo this test
- People taking certain medications (like antihistamines or beta-blockers) may need to stop them before the test
- The test is not recommended for people with active skin conditions in the test area
What to Expect During the Test
During the clinical trial for this allergen extract, researchers will be looking at several factors:
- The size of the wheal (raised bump) produced by different concentrations of the allergen extract
- How this compares to the reaction produced by a standard histamine solution
- Any side effects or adverse reactions to the test
The test is designed to be as safe and comfortable as possible, but as with any medical procedure, there's a small risk of side effects. These are usually mild and short-lived, such as itching or redness at the test site.